Collaborative IRB Training Initiative (CITI) Program: An online training program for human research protection and bioethics is designed specifically for all personnel that have a significant involvement in the planning, conduct, and analysis of any scientific activity that employs human research participants. It is sponsored by a consortium of IRB professionals and researchers from universities and medical schools across the country and is administered by the University of Miami. The course consists of training modules that are divided into two tracks: Biomedical Research and Social/Behavioral Research. The learning objectives of the CITI course are: - To provide an understanding of the historical perspectives, ethical principles, and federal regulations associated with the conduct of research with human participants;
- To provide a clear understanding of what constitutes informed consent process and how it must be applied in research involving humans;
- To provide basic information on the regulations and policies governing research with investigational drugs, biologics, and devices; and
- To provide a clear understanding of the ethical issues and federal regulations in force during the conduct of Social/Behavioral research, records based research and genetics research with human participants.
Procedure Prior to participating in human subjects research, the investigator and key personnel conducting the research under the jurisdiction of the UAB IRB: - Completes initial training requirement by one of the following methods (see GUI314):
- CITI Online Initial Course - CITI "Basic" Course
- National Institutes of Health Online - NIH Human Participant Protections Education for Research Teams
- NOTE: This course is no longer offered, but will be accepted as an investigator’s initial training if they used it to satisfy that requirement.
- UAB Graduate Course or School of Medicine/Public Health administered program GRD 717 or Clinical Research Training Program (UAB); or
- Provides documentation upon arriving at UAB of one of the following:
- An initial IRB training course from CITI (OIRB staff will determine whether it will satisfy the UAB IRB initial training requirement),
- Other initial IRB training course (OIRB staff will review course materials to determine whether it will satisfy the UAB IRB initial training requirement).
- A training course intended to meet the federal IRB training requirements that are offered by another institution that holds a Federalwide Assurance (FWA). Persons submitting certification of a training course other than the CITI course should also submit a description of the course (e.g., syllabus, course objectives, and outline). Depending on the date when the "transferred" training was completed, continuing IRB training may also be required.
- Completes initial ICH-GCP(E6) training on CITI if performing research on a study that meets the definition of a “clinical trial” regardless of the funding source.
- Completes continuing education requirements at least triennially (once every three years) of a course approved by the IRB (see GUI314).
If the required training is not completed, the investigator or key personnel will not be allowed to participate in the research activities. Management Staff: - Maintains the agreement with the CITI Program for web-based training;
- Verifies investigators and key personnel involved in research have completed the necessary training requirements.
- Completes initial or continuing education, as appropriate after joining the OIRB staff or provides documentation of satisfactory completion.
- Completes continuing education at least every 3 years – failure to do so will be documented in employee evaluation.
Reviewing Staff: - Completes initial or continuing education as appropriate after joining the OIRB staff or provides documentation of satisfactory completion.
- Completes continuing education at least every 3 years – failure to do so will be documented in employee evaluation.
- Accounts for and maintains IRB human subjects protections training database.
- Verifies investigators and key personnel involved in research have completed the necessary training requirements.
IRB Member: - Completes an orientation before being allowed to serve on the IRB, which includes the following (See PRO104 Procedure for Qualifications and Composition of IRBs and OIRB Staff):
- Educational session with management staff member (or delegate);
- Attending two or more IRB meetings as an observer;
- Reviewing materials pertaining to human subjects protections:
- UAB IRB policies and procedures,
- All IRB forms,
- The Belmont Report,
- The Clinical Research Resources Training and Guidance for Regulatory Compliance Handbook which includes:
- 45 CFR 46 and 164;
- 21 CFR 11, 50, 54, and 56;
- FDA Information Sheets for IRBs and Clinical Investigators;
- Additional Guidance on the FDA Compliance Manual on Investigators and IRBs;
- DHHS OCR Guidance on HIPAA Privacy in Research;
- DoD Guidance Document (GUI339);
- DOE Guidance Document (GUI338);
- Completes initial training in human subjects protections and biennial continuing education by completing a course approved by the IRB – failure to do so will result in not being allowed to serve on the IRB;
- Understands and is knowledgeable about strategies to maintain confidentiality of identifiable data, including storage, handling and sharing;
- Receives training through scheduled sessions through lectures incorporated into convened IRB meetings;
- May exercise the option to attend regional or national human subjects protection conferences or workshops;
- Completes a self-evaluation tool assessing their knowledge, and identifying educational needs for the coming year (see SUP413 UAB IRB Member Self-Evaluation Form);
- Recommends and has access to resources from the IRB in-house reference library to obtain additional information regarding the history and conduct of research activities.
Institutional Official: - Completes the OHRP Assurance training module.
- Completes other applicable training modules, as required.
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